腹腔鏡手術後のトロカール部位ヘルニア予防におけるDuramesh™と従来の縫合糸の比較：二重盲検ランダム化比較試験（TROCAR）の試験プロトコル
Lawrence Nip1,2, Sarah Zhao3,4, Rhys Thomas3
1The Abdominal Wall Unit, Croydon University Hospital, 530 London Road, Thornton Heath, London, CR7 7YE, UK. lscnip@doctors.org.uk.
Background:
Trocar-site hernia is an underappreciated condition with estimates of approximately 25% at 2 years follow-up. Duramesh™ has emerged as a novel product with potential benefits for incisional hernia prevention. The aim of this trial is to establish if Duramesh is superior to conventional suture for prevention of periumbilical trocar-site hernia following laparoscopic surgery.
Methods:
The TROCAR trial is a prospective single-centre, parallel arm, double-blind randomised controlled trial conducted in the United Kingdom. A total of 250 randomised participants (1:1 ratio) will be allocated to receive either Duramesh or conventional suture (J-vicryl or J-PDS). The primary outcome is the cumulative incidence of sonographically detected periumbilical trocar-site hernia at 2 years of the index operation. Secondary outcomes are 90-day surgical site occurrence (SSO), 90-day surgical site infection (SSI), 90-day rate of reoperation, 90-day mortality, length of hospital stay, and quality of life at 3 months, 1 year and 2 years measured using a modified EuraHS-QoL score and modified Carolinas Comfort Scale.
Conclusion:
TROCAR will provide level 1 evidence on trocar-site hernia prevention in both the emergency and elective settings.
Trial Registration:
Registration number ISRCTN14473961 (https://doi.org/10.1186/ISRCTN14473961). Registered on 14th April 2025.
